Advertisement

Developing the Corporate CMC Regulatory Compliance Strategy

  • John Geigert

Abstract

‘We have to move fast because the competition is on our tail; we have limited funds and staff to move our biopharmaceutical through clinical development so we cannot do everything and hire everybody we want; so what CMC must we absolutely have to do now to be successful, and what can we do at a later stage of clinical development?’

Keywords

Drug Product Drug Substance Biopharmaceutical Product Regulatory Submission Biopharmaceutical Company 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Copyright information

© Springer Science+Business Media New York 2004

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

Personalised recommendations